Lunsekimig for Chronic Obstructive Pulmonary Disease
(THESEUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called lunsekimig for people with COPD, a lung disease that makes breathing difficult, who do not respond well to current treatments. The study aims to evaluate the effectiveness and safety of lunsekimig compared to a placebo, a harmless pill with no effect, over about a year. Individuals who have had COPD for at least a year, experience frequent flare-ups, and are on certain medications but still struggle with symptoms might be a good fit. Participants will receive different doses of lunsekimig or a placebo to determine which works best. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering a chance to contribute to advancing COPD treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that you cannot have used any biologic therapy or systemic immunosuppressant within 8 weeks before the screening. It also requires that you have been on triple COPD therapy for at least 12 weeks.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that lunsekimig has been tested for safety in conditions like COPD and asthma. In these studies, participants generally tolerated lunsekimig well. Most side effects were mild to moderate, such as headaches or mild reactions at the injection site, while serious side effects were rare.
This clinical trial is in a later stage, indicating more is known about the treatment's safety. Earlier studies have already assessed safety in smaller groups. Although this does not eliminate all risks, it suggests that major safety issues are unlikely.12345Why do researchers think this study treatment might be promising for COPD?
Most treatments for Chronic Obstructive Pulmonary Disease (COPD), like bronchodilators and corticosteroids, focus on opening airways and reducing inflammation. But Lunsekimig works differently, aiming at a unique pathway to improve lung function and potentially slow disease progression. Researchers are particularly excited because Lunsekimig could offer a new mechanism of action that might complement or even surpass current therapies. This could provide hope for better management of COPD symptoms and improved quality of life for patients.
What evidence suggests that this trial's treatments could be effective for COPD?
Research has shown that lunsekimig may help treat Chronic Obstructive Pulmonary Disease (COPD), particularly in patients with a specific type of cell called an eosinophil. Early findings suggest that lunsekimig can reduce lung inflammation and improve breathing. Studies indicate it may lead to fewer flare-ups and better overall lung function. Although final results are pending, early data from previous studies offer hope for its effectiveness. This trial tests lunsekimig in different dose regimens, labeled as dose regimen A and dose regimen B, to find the best balance between safety and benefits.12346
Are You a Good Fit for This Trial?
Adults aged 40-80 with poorly controlled COPD and an eosinophilic phenotype can join this study. They must have a history of smoking, specific lung function test results, and at least one severe or two moderate flare-ups in the past year despite triple therapy for COPD.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous administrations of lunsekimig or matching placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lunsekimig
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University